None listed
Conditions
Interventions
Group 1 Type of group
Initial period of treatment (4 weeks): Zelmac 6mg twice a day. Then we proceed to suspend the treatment for 2 months and the recurrence is evaluated
Group name:Group 2 Type of group
Initial period of treatment (4 weeks): Zelmac 6mg twice a day. Then we proceed to continue treatment for 2 months and then the recurrence is evaluated
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female patients at least 18 years old • Diagnosis of IBS with abdominal pain / discomfort and constipation as main symptoms • In all patients, the absence of organic disease, the G-1 tract, malformation, cancer, intestinal inflammatory disorders, etc., must be documented with endoscopic or radiological evaluation of the intestine. According to international recommendations, after the onset of IBS symptoms and within the previous 5 years. • Ability and willingness to communicate well with the researcher and comply with the requirements of the study, including filling out the patient´s diary. • Written informed consent to participate in the study during the entire study.
Exclusion criteria
Exclusion criteria: • History of use of laxatives, which in the opinion of the investigator is consistent with severe dependence on laxatives. • Current or recent history (within 12 months) of alcohol or drug abuse. • History of malignancy within the previous 5 years (with the exception of correctly treated basal cell carcinoma or cervical carcinoma in situ). • Known history of cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other significant or inadequately controlled disease that could compromise the patient´s ability to participate and complete the study. Hypertensive patients should be well controlled with the treatment (satisfactory blood pressure values ​​with stable treatment since at least 3 months ago). L Patients should undergo a complete safety screening at admission to exclude these conditions and provide baseline safety. • Functional disorder of the upper Gl tract in which the treatment has not been stable in the last 3 months (Patients must also agree not to modify this treatment during the duration of the study). • Women who are pregnant or breastfeeding. • Fertile women who do not practice a medically proven contraceptive method for at least 6 weeks and who do not agree to continue it until at least 1 month after stopping treatment with Zelmac. • Use of other investigational drugs within the previous month or intention to use these drugs during the course of the study. • Intention and / or perception of regularly using other medication or agents and research that affect gastrointestinal motility, should be withdrawn during the selection period; and its use results in the patient being excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Functional rating scale for pain & distension Measure:Symptoms of pain and distension Timepoints:Daily record by the patient ; Outcome name:Bristol scale of stool form, filled by the patient Measure:Frequency of defecation and consistency Timepoints:Daily record by the patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The patient will be asked to answer the following question: In the last week, do you consider that you have had satisfactory relief from your IBS symptoms? The possible answers are: yes or no. Measure:Determination of global relief Timepoints:Daily record by the patient ; Outcome name:based on the -determination of global relief- made by the patient in the patients diary, a patient will be considered a responder when satisfactory relief is obtained in at least 2 of the 4 weeks. Measure:Determination of Response / Recurrence Timepoints:On visits 2. 3. 4 and 5 ; Outcome name:Registry of adverse events Measure:Safety Timepoints:When the event happens | — |
Countries
Argentina, Brazil, Chile, Ecuador, Mexico, Peru, Uruguay, Venezuela
Outcome results
None listed